Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms
- Conditions
- Atopic DermatitisEczema
- Registration Number
- NCT06268847
- Lead Sponsor
- Abyss Ingredients
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Phototype: I to V;<br><br> - Subjects with atopic skin (with at least 1 visible xerosis + inflammation on the<br> body);<br><br> - Subjects with a history background of asthma, rhinitis and/or allergic<br> conjunctivitis;<br><br> - Subjects with SCORAD between 8 and 30 (at least 50% or more having around 8-10);<br><br> - Subjects with BMI between 20 and 30 kg/m2 (limits included);<br><br> - Subjects who have not recently participated in another similar study;<br><br> - Willingness to take supplements for the duration of the study;<br><br> - Willingness not to use products likely to interfere with the test product (collagen,<br> hyaluronic acid, anti-stress products);<br><br> - Willingness not to change lifestyle habits;<br><br> - Willingness to avoid intensive UV exposure;<br><br> - Use of contraception that should not be modified during the study.<br><br> - Healthy subject;<br><br> - Mentally healthy subject according to Investigator's opinion;<br><br> - Subject having given his/her free informed, written consent;<br><br> - Subject agrees to taking photograph and then use the image after its<br> pseudonymization;<br><br> - Subject willing to adhere to the protocol and study procedures;<br><br> - Subject able to understand the study;<br><br> - Subject available to attend the study visits.<br><br>Exclusion Criteria:<br><br> - Pregnant or nursing woman or woman planning to get pregnant during the study;<br><br> - Cutaneous marks on the experimental areas, which could interfere with the assessment<br> of skin reactions;<br><br> - Subjects who have participated in the last 3 months or are currently participating<br> in another clinical trial that may interfere with the evaluation of the primary<br> endpoint (endpoint AD);<br><br> - Current administration of antibiotics;<br><br> - Known history of chronic disease such as congenital heart disease, liver or kidney<br> disease, or immune deficiency;<br><br> - Topical treatment with immunomodulators (tacrolimus or pimecrolimus) in the three<br> months prior to registration;<br><br> - Application of moisturizing products on the experimental area the day of the<br> inclusion of the study;<br><br> - Acute or chronic infectious diseases;<br><br> - Not meet inclusion criteria;<br><br> - Those undergoing aesthetic medicine (fillers, hyaluronic acid injections, botox)<br> that could interference in the experimental area;<br><br> - Subjects suffering Alimentary/Eating disorders (i.e. bulimia, psychogenic eating<br> disorders, etc.)<br><br> - Subjects having frequent stomach burn;<br><br> - Allergy or intolerance to any ingredient of the experimental food supplement;<br><br> - Subjects with diabetes mellitus;<br><br> - Fish and/or iodine allergy;<br><br> - Intestinal conditions or disorders (Crohn's disease, colitis, irritable bowel<br> syndrome, intestinal malabsorption...)<br><br> - Recent change, forecast of initiation of an hormonal treatment or change of the<br> usual hormonal treatment during the study or 3 months before the starting of the<br> study;<br><br> - Subject having undergone a surgery under general anesthesia within the previous<br> month;<br><br> - Exposure in UVA ray sunbed during the 3 months before the start of the study on the<br> experimental area or during the study;<br><br> - Subjects protected by the law;<br><br> - Subject employed by EUROFINS PRODUCT TESTING, COSMETICS & PERSONAL CARE SPAIN,<br> S.L.U.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SCORAD (SCORing Atopic Dermatitis)
- Secondary Outcome Measures
Name Time Method EASI (Eczema Area and Severity Index);Investigator Global Assessment scale;Corneometer;Transepidermal Water Loss (TEWL);Quality of Life Index - Perceived Stress;Participant's Satisfaction